EU MDR

So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing the technical file. One of the more common tasks is taking a look [...]

Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex. Navigating through these regulations requires a deep understanding of the nuances that [...]

Adverse Events in Europe The landscape of medical device safety in Europe is significantly influenced by the occurrence and management of adverse events. An adverse event in this context refers to any untoward medical [...]

Medical device regulations are no joke. It's pretty important to get the regulations right, since even a single missed data, if significant enough, can result in years of delay in getting a CE mark. [...]

Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start that new Clinical Evaluation Report (CER) project for Europe, or remediate your current documents based on Notified Body feedback... and [...]

Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat, and monitor literally all health disorders. And for this very reason, no [...]

Clinical trials are important. The discovery of any new medical treatments is a standard step for testing the device on human subjects in a safe, controlled environment where the results and process can be [...]

Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest contributors behind the thousands of devices that get conformity approval each year. However, good medical [...]

A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and well-executed QMS is your security man who controls what goes in and [...]

The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each day, we advance a little more to better human health. Thousands of people worldwide work [...]

The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so that you get a safe and effective device at the end of [...]

Developing a medical device is not a one-step process. There are hundreds of little steps, from drawing the design to finalizing it to actually creating the device. Between all these steps, there is always [...]